电针刺激治疗家庭暴力女性受害者的精神后遗症:一项评估者盲法随机对照试验的研究方案
Electrical acupoint stimulation for psychiatric sequelae in women victims of domestic violence: study protocol for an assessor-blind randomized controlled trial.
作者信息
Yang Sichang, Tiwari Agnes, Cheung Denise Shuk Ting, Cheng Calvin Pak Wing, Chan Mei Yan, Chen Haiyong, Zhang Zhang-Jin
机构信息
School of Chinese Medicine, LKS Faculty of Medicine, The University of Hong Kong, 3 Sassoon Road, Pokfulam, Hong Kong, China.
Department of Chinese Medicine, the University of Hong Kong-Shenzhen Hospital (HKU-SZH), Shenzhen, China.
出版信息
BMC Complement Med Ther. 2025 Sep 1;25(1):316. doi: 10.1186/s12906-025-05033-3.
BACKGROUND
Domestic violence is a global public health problem linked to mental illness morbidity. A significant proportion of domestic violence victims have been found to exhibit unsatisfactory response rates to first-line treatments and display low acceptance levels towards psychological interventions. To improve the therapeutic effectiveness for this population, we aim to develop an electrical acupoint stimulation modality that integrates clinic-based and home-based therapies, with the goal of improving the psychiatric symptoms experienced by women victims of domestic violence.
METHODS
This is an assessor-blinded randomized controlled trial, consisting of 110 women victims diagnosed with depression. The patients will be randomly assigned to either the treatment group or the routine care group in a 1:1 ratio. The treatment group will receive electrical acupoint stimulation over a period of 12 consecutive weeks, in addition to their routine care. On the other hand, the routine care group will not receive any electrical acupoint stimulation until the end of the 12-week study. The primary outcome of the study is the mean change in the score of Beck Depression Inventory-II (BDI-II) from baseline to the end of the 12-week treatment. Secondary outcomes will include the 17-item Hamilton Depression Rating Scale (HAMD-17), 10-Item Perceived Stress Scale (PSS-10), PTSD Check List-Civilian Version (PCL-C), Insomnia Severity Index (ISI), 12-Item Short Form Survey (SF-12), as well as any observed adverse events.
DISCUSSION
If effective, this electrical acupoint stimulation modality could have significant clinical and research implications for women victims of domestic violence with psychiatric sequelae.
TRIALS REGISTRATION
ClinicalTrials.gov as NCT05102253. Registered 1 November 2021. https://www.
CLINICALTRIALS
gov/study/NCT05102253 .
背景
家庭暴力是一个与精神疾病发病率相关的全球公共卫生问题。已发现相当一部分家庭暴力受害者对一线治疗的反应率不理想,且对心理干预的接受程度较低。为提高针对这一人群的治疗效果,我们旨在开发一种将门诊治疗和家庭治疗相结合的电穴位刺激疗法,以改善家庭暴力女性受害者所经历的精神症状。
方法
这是一项评估者盲法随机对照试验,由110名被诊断为抑郁症的家庭暴力女性受害者组成。患者将按1:1的比例随机分配到治疗组或常规护理组。治疗组除接受常规护理外,还将连续12周接受电穴位刺激。另一方面,常规护理组在12周研究结束前不接受任何电穴位刺激。该研究的主要结局是贝克抑郁量表第二版(BDI-II)评分从基线到12周治疗结束时的平均变化。次要结局将包括17项汉密尔顿抑郁量表(HAMD-17)、10项感知压力量表(PSS-10)、创伤后应激障碍检查表平民版(PCL-C)、失眠严重程度指数(ISI)、12项简短调查(SF-12)以及任何观察到的不良事件。
讨论
如果有效,这种电穴位刺激疗法可能对有精神后遗症的家庭暴力女性受害者具有重大的临床和研究意义。
试验注册
ClinicalTrials.gov,编号NCT05102253。于2021年11月1日注册。https://www.CLINICALTRIALS.gov/study/NCT05102253 。